National Council for Prescription Drug Programs indexing - billing unit

Manufacturer: National Council for Prescription Drug Programs
Effective date: 2012-07-24
Label type: Indexing - Billing Unit
Version: 1
Source: full-release
Hydrated at: 2026-06-05 01:30:49

Label at a glance#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0607-51	EA - Each	0078-0607	370f1dce-3eb2-497b-971a-6e448e815d4f	1	2012-07-24

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0078-0607	0078-0607-51

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022527-001	GILENYA	FINGOLIMOD HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21
N022527-002	GILENYA	FINGOLIMOD HYDROCHLORIDE	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N022527-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022527-001	10543179	2027-12-25	U-2719		2020-01-28
N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19
N022527-002	9592208*PED	2032-09-30		Pediatric extension

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL		RLD	2018-05-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL	AB	RLD	2018-05-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL	AB	RLD	2018-05-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022527-001	GILENYA	EQ 0.5MG BASE	CAPSULE / ORAL	AB	RLD, RS	2010-09-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022527-002	GILENYA	EQ 0.25MG BASE	CAPSULE / ORAL	AB	RLD	2018-05-11	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N022527-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022527-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022527-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022527-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022527-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022527-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022527-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022527-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022527-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022527-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022527-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022527-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022527-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022527-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022527-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022527-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022527-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022527-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022527-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022527-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022527-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022527-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022527-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022527-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022527-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022527-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022527-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022527-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022527-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022527-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022527-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022527-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022527-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022527-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022527-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022527-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022527-001	AB	1	`053a50430f4f…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 293 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-001	8324283	2026-03-29		Drug product	2013-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-001	8324283*PED	2026-09-29		Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-001	9187405	2027-06-25	U-2613		2015-12-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-001	9187405*PED	2027-12-25		Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-001	8324283	2026-03-29		Drug product	2013-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-001	8324283*PED	2026-09-29		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-001	9187405	2027-06-25	U-2613		2015-12-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-001	9187405*PED	2027-12-25		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-002	9592208	2032-03-30	U-2315	Drug product	2018-06-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022527-002	9592208*PED	2032-09-30		Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-001	8324283	2026-03-29		Drug product	2013-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-001	8324283*PED	2026-09-29		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-001	9187405	2027-06-25	U-2613		2015-12-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-001	10543179	2027-12-25	U-2719		2020-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022527-001	9187405*PED	2027-12-25		Pediatric extension		`2680178bc6a6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022527-001	NPP	2021-05-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022527-001	PED	2021-11-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022527-002	NS	2021-05-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022527-002	PED	2021-11-11	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N022527-001	NPP	2021-05-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022527-001	PED	2021-11-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022527-002	NS	2021-05-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022527-002	PED	2021-11-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022527-001	NPP	2021-05-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022527-001	PED	2021-11-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022527-002	NS	2021-05-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022527-002	PED	2021-11-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022527-001	NPP	2021-05-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022527-001	PED	2021-11-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022527-002	NS	2021-05-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022527-002	PED	2021-11-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022527-001	NPP	2021-05-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022527-001	PED	2021-11-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022527-002	NS	2021-05-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022527-002	PED	2021-11-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022527-001	NPP	2021-05-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022527-001	PED	2021-11-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022527-002	NS	2021-05-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022527-002	PED	2021-11-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022527-001	NPP	2021-05-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022527-001	PED	2021-11-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022527-002	NS	2021-05-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022527-002	PED	2021-11-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022527-001	NPP	2021-05-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022527-001	PED	2021-11-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022527-002	NS	2021-05-11	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022527-002	PED	2021-11-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022527-001	NPP	2021-05-11	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022527-001	PED	2021-11-11	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022527-002	NS	2021-05-11	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022527-002	PED	2021-11-11	`ea99ee380514…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gilenya	FINGOLIMOD HCL	Novartis Pharmaceuticals Corporation	cc9e1c8c-0e2b-44e2-878b-27057f786be9	2026-07-22	Warnings, Adverse reactions	Exact identifier ndc (package): 0078-0607-51 ndc11 (package): 00078060751

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.